ANZCTR search results

This study aims to determine the effect of pre-operative chemotherapy in patients with resectable pancreatic cancer. Patients may be eligible to join this study if they are aged 18 years or more and have been diagnosed with cancer of the pancreas for which they plan to undergo surgery. All participants in this trial will undergo pre-operative chemotherapy with the drugs gemcitabine and nab-paclitaxel. The chemotherapy will be administered intravenously on day 1, day 8 and day 15 of a 28 day cycle. Patients will receive 2 cycles before undergoing surgery to remove their cancer. Participants will be assessed after surgery to determine whether all the cancerous tissue has been successfully removed. If all the cancer has been removed the patients will have another 4 cycles of chemotherapy with gemcitabine and nab-paclitaxel. If all the cancer is not removed during surgery, the treating clinician may decide that patients will receive radiotherapy everyday for 5 weeks, at the same time as receiving a continuous infusion of 5-flurouracil which will then be followed by 4 cycles of chemotherapy with gemcitabine and nab-paclitaxel. They may also decide to to treat patients with chemotherapy as described for patients who have had all their cancer removed. Blood tests and safety assessments will also be regularly conducted throughout the 12 month duration of the trial. The results from this study will be compared to previous data to determine whether pre-operative chemotherapy will improve resection, and thus, survival outcomes in patients with pancreatic cancer.

This is a clinical trial for patients with sleep apnea who cannot use the standard treatments: continuous positive airway pressure machines or mandibular advancement splints. In this study we are testing two types of treatments at the same time, one a drug-based treatment and one a diet and exercise treatment, in combination we hope these will reduce sleep apnea and control its daytime symptoms. Patients will be randomly assigned to one of two types of diet for 12 months, a standard low calorie diet versus a diet which is high in protein and low in glycemic index (Low GI). Both of these groups will participate in the same lifestyle program promoting activity, exercise and healthier choices. The drug based treatment is testing a drug called Armodafinil for 9 months. Armodafinil is a drug that promotes wakefulness but does not improve your sleep apnea directly. So we think that it may improve other secondary outcomes including ability to concentrate, particularly whilst driving. We will be comparing Armodafinil to an inert placebo which does not have any active ingredient.

This is a prospective, multicentre, single arm observational non-interventional investigator initiated study by members of the Australian Liver Association Clinical Trials Network. This study will examine the distribution of the known IL28B polymorphisms (rs12979860 and rs8099917 SNPs) in patients with treatment naive genotype 1 chronic hepatitis C being considered for treatment in Australian clinics. In addition to describing the IL28B distribution in the Australian cohort, we will investigate if there is any correlation between the IL28B genotype and pre-treatment factors such as the extent of liver fibrosis, viral load and HCV genotype 1 subtype.

Genital prolapse is a common condition with at least 1 woman in 10 undergoing surgery for this condition. It may be associated with urinary stress incontinence. Paradoxically, women suffering of severe genital prolapse may be continent. By reducing the prolapse during urodynamic assessment (barrier test), one can unmask urinary stress incontinence, called occult stress incontinence (OSI). Reducing the prolapse during urodynamic testing aims at mimicking the postoperative state. It is however unclear from the literature whether a positive barrier test is an indication for anti-incontinence surgery performed at the same time as prolapse surgery. Tensionfree Vaginal Tape (TVT) is an efficient anti-incontinence procedure and can be easily performed at the same time as prolapse surgery. Our study intends to randomise patients undergoing surgery for severe prolapse in two groups, one with usual prolapse surgery without any anti-incontinence procedure, the second with prolapse surgery and TVT. Urodynamics studies on patients with severe prolapse describe 36 to 80% of OSI. Our hypothesis is that 50% of patients operated for prolapse with a positive barrier test will develop urinary stress incontinence. TVT cures or improves stress incontinence in about 90% of patients. Combining TVT with prolapse surgery may therefore reduce the post-operative rate of stress incontinence from 50% to 10%. However, systematic use of TVT may expose patients to complications like voiding difficulties or de novo detrusor instability. The other option is to operate patients for prolapse and perform TVT under local anaesthesia only in those who develop distressing stress incontinence post-operatively.

Eye Movement Desensitisation and Reprogramming (EMDR) and exposure therapy are well established first line psychological treatments for Post-Traumatic Stress Disorder (PTSD)(Boudewyns et al., 1993; Boudewyns & Hyer, 1996; Edmond & Rubin, 2004; Lee et al., 2002; Montgomery & Ayllon, 1994; Power et al., 2002; Vaughan et al., 1994; Van Etten & Taylor, 1998). There have been few studies to date exploring changes in brain functioning following treatment in EMDR, which has left the underlying question of 'what is the mechanism by which the two therapies acheive their therapeutic effects' unresolved. Evidence as to what neurological changes occur as a result of treatment may help vindicate the efficacy of treatment modalities and aid understanding of treatment function. Positron Emission Tomography (PET) scanning enables research into changes in activation of different parts of the brain by measuring regional cerebral perfusion (blood flow), providing insight into this question by measuring brain activity. Magnetic Resonance Imaging (MRI) will enable accurate interpretation of the PET/CT scans and will aim to replicate or refute findings from a recent study that suggests effective treatment of PTSD is associated with an increase in hippocampal volume (Bossini et al., 2011). This project aims to also explore the therapeutic efficacy of EMDR and exposure therapy (in terms of symptom reduction), and the significance of the participant's experience of therapy; the impact of this experience on therapeutic efficacy and on the participant's quality of life and levels of functioning. Although there is an abundance of data evaluating the effectiveness of EMDR and prolonged exposure therapy in relation to symptom reduction (see refrences above), there are very few studies investigating participant's experience of therapy and the significance of this experience in their recovery both short and longer term; and only three major qualitative studies published on EMDR (Di Giorgio, Arnkoff, Glass, Lyhus & Walter, 2004; Edmond, Sloan & McCarty, 2004 and Ricci, Clayton and Shapiro, 2006). It was reported that due to the unusual nature of EMDR with the eye movements, exploration of participant's experiences of treatment was relevant, furthermore qualitative methods were felt to be the logical approach to gaining insight into these questions (Edmond, Sloan & McCarty, 2004).

The majority of patients with kidney failure have anaemia requiring erythropoietin therapy administered either subcutaneously or intravenously. Darbepoetin is a type of erythropoietin, which can be given via the subcutaneous or intravenous route. In patients prescribed subcutaneous darbepoetin, pain during and at the site of injection are common complaints. The aim of this study is to determine the differences in patients’ perceptions in the administration and pain between pre-filled syringe and pre-filled pen darbepoetin in patients already on subcutaneous pre-filled syringe darbepoetin therapy.

The communication difficulties associated with aphasia, an acquired language disorder, can have significant negative effects on an individual’s quality of life and participation in healthcare decisions. Currently, Australian health practitioners are not trained in techniques for communicating effectively with people with aphasia. The proposed study will investigate the impact of a communication training program on people with aphasia, health practitioners and health practitioner students. It is predicted that the program will improve communication efficiency between the groups, increasing the involvement of people with aphasia in their treatment programs and healthcare decisions and potentially improving patient and staff satisfaction. The techniques gained during the program may also assist health practitioners to interact effectively with patients with other communication needs.

This study is been carried out to investigate if transplanting minor salivary glands into the eyelid will provide adequate symptomatic relief from severe dry eye disease. Studies have shown that the composition of salivary secretions is fairly similar to that of natural tears, thus making it a promising potential source of tears for patients with severe dry eye disease. If the procedure is successful, it will restore a natural tear film to the eye, and help prevent the symptoms of dry eye including pain, visual disturbance and light sensitivity. If successful it will also reduce or even remove the need for artificial tear drops.

The trial aims to assess if designated driver programs may increase alcohol consumption intentions of community football club members. Participants will be randomised to receive a hypothetical scenario describing a post match celabration, or an identical scenario which also indicates that participants would have access to a designated driver to transport the participant home following the celebration. Participants will then be asked to indicate the quantity of alcohol they would intend to consume given this scenario.

This trial is being undertaken to assess whether the herbal formulation containing Testofen improves general sexual function, performance, and satisfaction in healthy males.